Stented prosthetic heart valve having wrap and methods of delivery and deployment

ABSTRACT

Systems and methods of delivering and deploying a stented prosthetic heart valve having a wrap that is automatically deployed to prevent or mitigate paravalvular leakage. In various embodiments, during transcatheter delivery of the stented prosthetic heart valve, the wrap is extends beyond a stent frame of the stented prosthetic heart valve so that the profile of the stented prosthetic heart valve is not increased during delivery. The disclosed embodiments are arranged and configured so that upon expansion of a stent frame of the stented prosthetic heart valve, a plurality of elongated members automatically pull the wrap distally into a deployed arrangement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/079,090, filed Mar. 24, 2016, now allowed, the entire teachings ofwhich are incorporated herein by reference.

BACKGROUND

The present disclosure generally relates to systems and methods fortranscatheter delivery and deployment of a stented prosthetic heartvalve having a wrap for preventing and/or mitigating paravalvularleakage.

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrioventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Recently, flexible prosthetic valves supported by stent structures thatcan be delivered percutaneously using a catheter-based delivery systemhave been developed for heart and venous valve replacement. Theseprosthetic valves may include either self-expanding orballoon-expandable stent structures with valve leaflets attached to theinterior of the stent structure. The prosthetic valve can be reduced indiameter, by crimping onto a balloon catheter or by being containedwithin a sheath component of a delivery catheter, and advanced throughthe venous or arterial vasculature. Once the prosthetic valve ispositioned at the treatment site, for instance within an incompetentnative valve, the stent structure may be expanded to hold the prostheticvalve firmly in place. One example of a stented prosthetic valve isdisclosed in U.S. Pat. No. 5,957,949 to Leonhardt et al. entitled“Percutaneous Placement Valve Stent.” Another example of a stentedprosthetic valve for a percutaneous pulmonary valve replacementprocedure is described in U.S. Patent Application Publication No.2003/0199971 A1 and U.S. Patent Application Publication No. 2003/0199963A1, both filed by Tower et al.

Although transcatheter delivery methods have provided safer and lessinvasive methods for replacing a defective native heart valve, leakagebetween the implanted prosthetic valve and the surrounding native tissueis a recurring problem. Leakage sometimes occurs due to the fact thatminimally invasive and percutaneous replacement of cardiac valvestypically does not involve actual physical removal of the diseased orinjured heart valve. Rather, the replacement stented prosthetic valve isdelivered in a compressed condition to the valve site, where it isexpanded to its operational state within the valve. Calcified ordiseased native leaflets are pressed to the side walls of the nativevalve by the radial force of the stent frame of the prosthetic valve.These calcified leaflets do not allow complete conformance of the stentframe with the native valve and can be a source of paravalvular leakage(PVL). Significant pressure gradients across the valve cause blood toleak through the gaps between the implanted prosthetic valve and thecalcified anatomy.

Embodiments hereof are related to systems and methods for transcatheterdelivery and deployment of a stented prosthetic heart valve having awrap for preventing and/or mitigating paravalvular leakage.

SUMMARY

The disclosure relates to systems and methods of delivering anddeploying a stented prosthetic heart valve having a wrap that isautomatically deployed to mitigate or assist in the prevention ofparavalvular leakage. In various embodiments, during transcatheterdelivery of the stented prosthetic heart valve, the wrap is securedeither in front of or behind (i.e. distal to or proximal to) a stentframe of the stented prosthetic heart valve. The disclosed embodimentsare arranged and configured so that upon expansion of the stent framefrom a compressed, delivery arrangement, a plurality of elongatedmembers spaced around the stent frame automatically pull the wrapproximally over and around the stent frame. In other embodiments, thewrap is pulled upwardly, inverting itself in the process.

Embodiments disclosed herein can reliably deploy the wrap andeffectively reduce stasis without adding an additional step to thedelivery process that needs to be performed by a clinician. Furtherembodiments are also beneficial since they do not increase the profileof the stented prosthetic heart valve during delivery as compared to asimilar stented prosthetic heart valve having a fixed wrap, which isparticularly important for transcatheter delivery procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exemplary delivery device for delivering and deploying astented prosthetic heart valve (not shown), the delivery device havingan inner shaft assembly and an optional outer sheath assembly.

FIG. 1B is a schematic illustration of the delivery device of FIG. 1Awith the stented prosthetic heart valve having a paravalvular leakpreventing wrap loaded thereto, the stented prosthetic heart valve andthe wrap secured to an inner shaft assembly in a delivery arrangement(the outer sheath assembly not shown).

FIG. 1C is a schematic illustration of the delivery device of FIGS.1A-1B with the stented prosthetic heart valve and the wrap in a deployedarrangement, prior to release from the delivery device.

FIG. 1D is a side view of the delivery arrangement of the stentedprosthetic heart valve and the wrap of FIG. 1B (a plurality of elongatedmembers interconnecting the wrap to a stent frame of the stentedprosthetic heart valve are not shown for clarity).

FIG. 1E is a side view of the deployment arrangement of the wrap thestented prosthetic heart valve of FIG. 1C.

FIG. 2A is a front view of a stented prosthetic heart valve similar tothat of FIGS. 1D-1E, the stented prosthetic heart valve secured over thedelivery device in a compressed arrangement for delivery; wherein a wrapof the stented prosthetic heart valve extends beyond the stent frame(the delivery device is only partially shown and the valve leaflets arenot shown for clarity).

FIG. 2B is a partial, schematic illustration of the stented prostheticheart valve and wrap of FIG. 2A in the compressed, delivery arrangement.

FIG. 2C is a partial, schematic illustration of the stented prostheticheart valve of FIG. 2A-2B illustrating a representative elongated memberinterconnecting the wrap to the stent frame.

FIG. 2D is a front view of the stented prosthetic heart valve of FIGS.2A-2C in a partially deployed arrangement; wherein the stent frame ispartially expanded and the elongated members attached thereto havestarted to pull the wrap over and onto the stent frame.

FIG. 2E is a perspective view of the stented prosthetic heart valve ofFIGS. 2A-2D in a deployed arrangement; wherein the stented prostheticheart valve is released from the delivery device and the wrap is securedover the stent frame.

FIG. 2F is a partial, schematic illustration of the stented prostheticheart valve and wrap of FIGS. 2A-2E in the deployed arrangement.

FIG. 2G is a partial, schematic illustration of the stented prostheticheart valve of FIGS. 2A-2F in the deployed arrangement (only oneelongated member is shown for clarity).

FIG. 3A is a perspective view of a stented prosthetic heart valve havinga stent frame having a wrap secured over the delivery device in anexpanded, deployed arrangement (the delivery device is only partiallyshown and the valve leaflets are not shown for clarity).

FIG. 3B is a schematic illustration of the wrap of the stentedprosthetic heart valve of FIG. 3A in the delivery arrangementillustrating how one representative elongated member is secured in anoffset manner to two cells of the stent frame.

FIG. 3C is a schematic illustration of the wrap of FIGS. 3A-3B when thestented prosthetic heart valve of FIG. 3A in an expanded arrangement.

FIG. 4A is a front view of a stented prosthetic heart valve having astent frame secured over the delivery device (the delivery device isonly partially shown and the valve leaflets are not shown for clarity);the stented prosthetic heart valve having a wrap extends beyond thestent frame in a delivery arrangement.

FIG. 4B is a perspective view of the stented prosthetic heart valve ofFIG. 4A in an expanded, deployed arrangement prior to releasing thestented prosthetic heart valve from the delivery device.

FIG. 4C is a schematic illustration of the stented prosthetic heartvalve of FIGS. 4A-4B illustrating how one representative elongatedmember can be secured to one of a plurality of cells of the stent frame.

FIG. 5A is a perspective view of a partially assembled stentedprosthetic heart valve having a wrap; the stented prosthetic heart valvefurther having a stent frame secured over the delivery device (thedelivery device is only partially shown and the valve leaflets are notshown for clarity).

FIG. 5B is a schematic illustration of the stented prosthetic heartvalve of FIG. 5A illustrating how one representative elongated member issecured to one of a plurality of cells of the stent frame.

FIG. 5C is a schematic illustration of the stented prosthetic heartvalve of FIGS. 5A-5B with the stented prosthetic heart valve and thewrap loaded onto the delivery device (only part of which is shown).

FIG. 5D is a schematic illustration of the stented prosthetic heartvalve of FIGS. 5A-5C with the stented prosthetic heart valve in anexpanded, deployed arrangement, which automatically positions the wrapover and onto the stent frame.

FIG. 5E is a perspective view of the stented prosthetic heart valve ofFIGS. 5A-5D illustrating the stented prosthetic heart valve in anexpanded, deployed arrangement; wherein the wrap is folded over itselfonto the stent frame.

FIG. 6A is a partial, schematic illustration of another embodiment of astented prosthetic heart valve having a wrap secured to a stent framewith a plurality of elongated members, the stented prosthetic heartvalve in a compressed, delivery arrangement and the wrap extendingbeyond the stent frame (valve leaflets of the stented prosthetic heartvalve are not shown for clarity).

FIG. 6B is a partial, schematic illustration of the stented prostheticheart valve of FIG. 6A in a transitory position in between thecompressed, delivery arrangement and an expanded, deployed arrangement.

FIG. 6C is a partial, schematic illustration of the stented prostheticheart valve of FIGS. 6A-6B in the expanded, deployed arrangement;wherein the wrap is positioned over the stent frame.

FIG. 7A is a partial, schematic illustration of another embodiment of astented prosthetic heart valve having a wrap secured to a stent framewith a plurality of elongated members, the stented prosthetic heartvalve in a compressed, delivery arrangement and the wrap extendingbeyond the stent frame (valve leaflets of the stented prosthetic heartvalve are not shown for clarity).

FIG. 7B is a partial, schematic illustration of the stented prostheticheart valve of FIGS. 7A in the expanded, deployed arrangement; whereinthe wrap is positioned over the stent frame.

FIG. 8A is a partial, schematic illustration of another embodiment of astented prosthetic heart valve having a wrap secured to a stent framewith a plurality of elongated members, the stented prosthetic heartvalve in a compressed, delivery arrangement and the wrap extendingbeyond the stent frame (valve leaflets of the stented prosthetic heartvalve are not shown for clarity).

FIG. 8B is a partial, schematic illustration of the stented prostheticheart valve of FIGS. 8A in the expanded, deployed arrangement; whereinthe wrap is positioned over the stent frame.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician. “Distal” or“distally” are a position distant from, or in a direction away from theclinician. “Proximal” and “proximally” are a position near or in adirection toward the clinician. Although the present disclosure has beendescribed with reference to preferred embodiments, workers skilled inthe art will recognize that changes can be made in form and detailwithout departing from the spirit and scope of the present disclosure.

By way of background, general components of one non-limiting example ofa delivery device 1 with which the present disclosures are useful areillustrated in FIGS. 1A-1E. The delivery device 1 is arranged andconfigured for percutaneously delivering a stented prosthetic heartvalve 10 (hereinafter “prosthetic valve”) to a patient's nativedefective heart valve. The delivery device 1 includes an optional outersheath assembly 2, an inner shaft assembly 4, and a handle assembly 6.One or more sutures 12 are provided, and can be considered part of thedelivery device 1 in some embodiments or as part of the prosthetic valve10 in other embodiments. The delivery device 1 provides a loadeddelivery arrangement (FIG. 1B) in which the prosthetic heart valve 10 isloaded over the inner shaft assembly 4 and is compressively retained ona spindle 8 or the like by the sutures 12. As is schematicallyillustrated in FIGS. 1B-1C the compression on the prosthetic valve 10can be adjusted with one or more sutures 12. Once loaded and compressed,the prosthetic valve 10 is located at the target site, tension in thesutures 12 is lessened to permit the prosthetic valve 10 to self-expand,partially releasing and ultimately fully deploying the prosthetic valve10 from the inner shaft assembly 4 (see FIG. 1B). In the illustratedembodiment, the outer sheath assembly 2, where provided, includes acapsule 9 that is selectively disposed over the prosthetic valve 10 thatassists in constraining the prosthetic valve 10 in the loaded orcompressed arrangement and can be retracted by the handle assembly 6 toexpose the prosthetic heart valve 10.

As referred to herein, stented prosthetic heart valves or “prostheticvalves” useful with and/or as part of the various systems and methods ofthe present disclosure may assume a wide variety of differentconfigurations, such as a biostented prosthetic heart valve havingtissue leaflets or a synthetic heart valve having polymeric, metallic,or tissue-engineered leaflets, and can be specifically configured forreplacing any heart valve. Thus, the prosthetic valves useful with thesystems and methods of the present disclosure can be generally used forreplacement of a native aortic, mitral, pulmonic, or tricuspid valve,for use as a venous valve, or to replace a failed bioprosthesis, such asin the area of an aortic valve or mitral valve, for example.

In general terms, the prosthetic valves of the present disclosureinclude a stent or stent frame maintaining a valve structure (tissue orsynthetic), with the stent frame having a normal, expanded arrangementand collapsible to a compressed arrangement for loading within thedelivery device. The stent frame is normally constructed to self-deployor self-expand when released from the delivery device. For example, theprosthetic valve useful with the present disclosure can be a prostheticvalve sold under the trade name CoreValve® available from MedtronicCoreValve, LLC. Other non-limiting examples of transcatheter heart valveprostheses useful with systems and methods of the present disclosure aredescribed in U.S. Publication Nos. 2006/0265056; 2007/0239266; and2007/0239269, the teachings of each which are incorporated herein byreference. The stents or stent frames are support structures thatcomprise a number of struts or wire portions arranged relative to eachother to provide a desired compressibility and strength to theprosthetic valve. In general terms, the stents or stent frames of thepresent disclosure are generally tubular support structures having aninternal area in which valve structure leaflets will be secured. Theleaflets can be formed from a variety of materials, such as autologoustissue, xenograph material, or synthetics as are known in the art. Theleaflets may be provided as a homogenous, biological valve structure,such as porcine, bovine, or equine valves. Alternatively, the leafletscan be provided independent of one another (e.g., bovine or equinepericardial leaflets) and subsequently assembled to the supportstructure of the stent frame. In another alternative, the stent frameand leaflets can be fabricated at the same time, such as may beaccomplished using high-strength nano-manufactured NiTi films producedat Advance BioProsthetic Surfaces (ABPS), for example. The stent framesupport structures are generally configured to accommodate at least two(typically three) leaflets; however, replacement prosthetic valves ofthe types described herein can incorporate more or less than threeleaflets.

Some embodiments of the stent frames can be a series of wires or wiresegments arranged such that they are capable of self-transitioning froma compressed or collapsed arrangement to the normal, radially expandedarrangement. In some constructions, a number of individual wirescomprising the stent frame support structure can be formed of a metal orother material. These wires are arranged in such a way that the stentframe support structure allows for folding or compressing or crimping tothe compressed arrangement in which the internal diameter is smallerthan the internal diameter when in the normal, expanded arrangement. Inthe compressed arrangement, such a stent frame support structure withattached leaflets can be mounted onto a delivery device. The stent framesupport structures are configured so that they can be changed to theirnormal, expanded arrangement when desired, such as by the relativemovement of one or more sheaths relative to a length of the stent frame.

The stent frame support structures in embodiments of the presentdisclosure can be formed from a shape memory material such as a nickeltitanium alloy (e.g., Nitinol™). With this material, the supportstructure is self-expandable from the compressed arrangement to thenormal, expanded arrangement, such as by the application of heat,energy, and the like, or by the removal of external forces (e.g.,compressive forces). This stent frame support structure can also becompressed and re-expanded multiple times without damaging the structureof the stent frame. In addition, the stent frame support structure ofsome embodiments may be laser-cut from a single piece of material or maybe assembled from a number of different components. For these types ofstent frame structures, one example of a delivery device that can beused includes a catheter with a retractable sheath that covers the stentframe until it is to be deployed, at which point the sheath can beretracted to allow the stent frame to self-expand. Further details ofsuch embodiments are discussed below.

The non-limiting prosthetic valve 10 useful with systems and methods ofthe present disclosure is illustrated in FIGS. 1D-1E. As a point ofreference, the prosthetic valve 10 has a compressed, deliveryconfiguration as is shown in FIG. 1D (e.g., when compressively retainedon the inner shaft assembly 4, and, perhaps, within a capsule 9). Theprosthetic valve 10 also has a normal, expanded configuration as isshown in FIG. 1E. The prosthetic valve 10 includes a stent or stentframe 14, a valve structure 16 and a wrap 40 interconnected to the stentframe with a plurality of elongated members 54 (e.g., sutures, cords,wires, ribbons or the like). The stent frame 14 can assume any of theforms described above, and is generally constructed so as to beself-expandable from the compressed arrangement (FIG. 1D) to the normal,expanded delivery arrangement (FIG. 1E). In other embodiments, the stentframe 14 is expandable to the expanded arrangement by a separate device(e.g., a balloon internally located within the stent frame 14). Thestent frame 14 is at least partially formed by a plurality of cells 18defined by a plurality of segments 20 that are adjoined at nodes 22. Thevalve structure 16 is assembled to the stent frame 14 and provides twoor more (typically three) leaflets 24. The valve structure 16 can assumeany of the forms described above, and can be assembled to the stentframe 14 in various manners, such as by sewing the valve structure 16 toone or more of the segments 20 defined by the stent frame 14.

The prosthetic valve 10 FIGS. 1D-1E is configured for replacing anaortic valve (not shown). Alternatively, other shapes are alsoenvisioned, adapted for the specific anatomy of the valve to be replaced(e.g., prosthetic valves in accordance with the present disclosure canalternatively be shaped and/or sized for replacing a native mitral,pulmonic, or tricuspid valve). Regardless, the valve structure 16 can bearranged to extend less than an entire length of the stent frame 14. Inparticular, the valve structure 16 can be assembled to, and extendalong, a first end 26 of the prosthetic valve 10, whereas a second end28 can be free of the valve structure 16 material. A wide variety ofother constructions are also acceptable and within the scope of thepresent disclosure. For example, the valve structure 16 can be sized andshaped to extend along an entirety, or a near entirety, of a length ofthe stent frame 14.

In certain embodiments, expansion and contraction of the stent frame 14is controlled with one or more sutures 12 actuated by the deliverydevice 1 as described above. The sutures 12 can be wrapped around theouter circumference of the stent frame 14. At the first and second ends26, 28, for example, the compression sutures 12 can be woven through aplurality of eyelets 30, 32 provided in the stent frame 14 to providefor, with the assistance of the delivery device 1, compressing andreleasing of the compressive tension placed on the stent frame 14. Inaddition, one or more sutures 12 can be positioned around the stentframe 14 between the first and second ends, 26, 28, to provide uniformcompressing the stent frame 14.

The prosthetic valves disclosed herein include a paravalvular leakagemitigation and prevention wrap, such the wrap 40 of FIGS. 1B-1E. In someembodiments, during transcatheter, transfemoral or subclavian delivery,for example, of the prosthetic valve 10, the wrap 40 is positioned infront of (i.e. distal to) the stent frame 14. In the case of transapicaldelivery, the wrap is positioned behind (i.e. proximal to) the stentframe 14. Regardless of the distal or proximal placement of the wrap 40with respect to the stent frame 14, the plurality of elongated members54 interconnecting the wrap 40 to the stent frame 14 are arranged andconfigured so that upon expansion of the stent frame 14 from thecompressed, delivery arrangement of FIG. 1B and 1D to the expandedconfiguration of FIGS. 1C and 1E, the elongated members 54 automaticallypull the wrap 40 proximally over and around the stent frame 14. In someembodiments, during delivery of the prosthetic valve 10, the wrap 40 ispositioned at least partially around stent frame 14 and the elongatedmembers 54 pull the rest of the wrap 40 over and around the stent frame14. In some embodiments, during delivery of the prosthetic valve 10, thewrap 40 is completely positioned around stent frame 14 and the elongatedmembers 54 change the configuration of the wrap 40 from a deliveryconfiguration to a deployed configuration.

In some embodiments further discussed below, the wrap is pulledupwardly, inverting itself in the process. In some embodiments disclosedherein, the wrap generally comprises a cylindrical body of materialhaving a secured end and a free end. In some embodiments, the wrap maycomprises a portion of a cylindrical body of material or anon-cylindrical body of material having a secured end and a free end.The wrap material can be made of a flexible material such as polyesterweave, velour, and tissue, for example. The wrap can have a diameterthat is roughly the same as a diameter of the expanded stent frame. Thewrap can also include edging on one or more of the free and securedends. If edging is provided on the secured end, it can be used toconnect the wrap to an internal skirt provided inside the stent frame,if provided (not shown).

A prosthetic valve 110, as seen in FIGS. 2A-2G, can be delivered anddeployed with the delivery device 1 in the manner as schematicallyillustrated and described with respect to FIGS. 1A-1E. The prostheticvalve 110 is generally identical to that illustrated and described withrespect to FIGS. 1B-1E. The prosthetic valve 110 includes a wrap 140that generally comprises a cylindrical body of material 142 having asecured end 144 and a free end 146. The secured end 144 of the wrap 140can be secured to the stent frame 114 with one or more attachmentsutures 152 threaded through the eyelets 130 of the stent frame 114.FIG. 2A illustrates the prosthetic valve 110 held in a compressed,delivery arrangement on a shaft 4 of the delivery device 1 (partiallyshown) with at least one compression suture 112. In the compressed ordelivery arrangement, the wrap 140 extends from or beyond (i.e. distalto) the stent frame 114 so that the profile, or circumference, of theprosthetic valve 110 is not increased during delivery by the addition ofthe wrap 140. It is highly desirable that the profile of the prostheticvalve 110 be as small as possible to facilitate transcatheter deliveryof the prosthetic valve 110.

As best shown in FIGS. 2C and 2F, to fully deploy the wrap 140, aplurality of elongated members 154 are provided, which are configured toautomatically pull the wrap 140 into position upon expansion of theprosthetic valve 110 during deployment. The elongated members 154 can besutures, cords, wires, ribbons or the like. In the illustratedembodiment, the wrap 140 is actuated with six elongated members 154equally spaced around the stent frame 114 and attached proximate thefree end 146 of the wrap 140 (not all of the elongated members 154 arevisible, more or less elongated members can alternatively be utilized).The wrap 140 can optionally include openings 148 in which the attachmentand elongated members 154 are secured or pass through as will be furtherdiscussed below. As is generally illustrated in FIGS. 2C and 2F (onlyone exemplary elongated member 154 is illustrated), each elongatedmember 154 extends from the free end 146 and is wrapped around animmediately adjacent pivot node 122 a of the stent frame 114, then theelongated member 154 is woven across two cells 118 a of the stent frame114 to a second node 122 b to which the respective elongated member 154is attached. This “two-cell” threading arrangement provides a sufficientamount of slack in the respective elongated member 154 to allow the wrap140 to be positioned proximal to the stent frame 114 when the stentframe 114 is in the compressed, delivery configuration, as isillustrated in FIG. 2A. It will be understood that the number of cells118 a in which the elongated member 154 spans can vary based on thestent frame 114 design. The elongated members 154 are woven andconfigured to provide a length of travel required to pull the wrap 140from the delivery arrangement to the deployed arrangement. When thestent frame 114 is allowed to expand by releasing tension in thecompression sutures 112 or otherwise, each elongated member 154 ispulled across the expanding exterior circumference of the stent frame114, thus also pulling the wrap 140 proximally into position over thestent frame 114 as is shown in FIGS. 2B-2G. In other words, as the stentframe 114 expands, the elongated members 154 pull the free end 146 ofthe wrap 140 until the free end 146 flips over the secured end 144 andthe free end 146 is proximal to the secured end 144 in the deployedarrangement. The expansion of the stent frame 114, and thus, thecorresponding deployment of the wrap 140 can be controlled and adjusted,as needed, by either increasing or decreasing the tension in thecompression suture(s) 112 with delivery device 1.

An alternate prosthetic valve 110′, which is generally illustrated inFIGS. 3A-3C, is almost identical to that of FIGS. 2A-2G with theexception that each elongated member 154 is woven to be offset toprovide a greater suture length, which may be required for wider wrapconfigurations requiring that a second or free end 146 of the wrap 140be pulled a greater distance from the delivery arrangement (FIG. 3B) tothe deployment arrangement (FIGS. 3A and 3C). Having the elongatedmembers 154 woven in a way in which they are offset also results inrippling and ridges 143 in the wrap body material 142 that is believedto help fill gaps around the stent frame 114 to further prevent anypotential paravalvular leakage. As illustrated, each elongated member154 extends from a free end 146 of the wrap 140 and to an adjacent node122 c opposite the direction of the node 122 d on which the elongatedmember 154 is ultimately attached, two cells 118 b away. As generallyillustrated in FIGS. 3B-3C, as viewed from the first end 126, therespective elongated member 154 extends clockwise to and wraps aroundadjacent pivot node 122 c and then counterclockwise back across a widthof two or more cells 118 b to the next node 122 d to which the elongatedmember 154 is secured by tying or the like. As will be understood,although not illustrated, each elongated member 154 can alternativelyextend counterclockwise to and wrap around an adjacent pivot node andthen clockwise back across a width of two or more cells to the next nodeto which the elongated member is secured. As with the prior disclosedembodiments, a valve structure of the prosthetic valve 110′ is notillustrated in the figures for clarity.

A further prosthetic valve 210 is illustrated in FIGS. 4A-4C. In thisembodiment, which is largely similar to those disclosed above, there area plurality of (e.g. six) elongated members 254 equidistantly spacedaround and secured to a free end 246 of a wrap 240 (not all of theelongated members are visible). Instead of the elongated members 254extending across two or more cells 218 of the stent frame 214, as inprior embodiments, the elongated members 254 are each woven around onerespective cell 218 (i.e. “one-cell” threading). As best illustrated inFIG. 4C illustrating the threading of one representative elongatedmember 254, each elongated member 254 extends from a first node 222 a towhich the elongated member 254 is attached. The respective elongatedmember 254 then is threaded across an adjacent cell 218 to a second node222 b around which the respective elongated member 254 is wound. Therespective elongated member 254 is then directed toward the free end 246of the wrap 240, which includes a first hole 248 a, through which theelongated member 254 is threaded. The respective elongated member 254 isthen threaded back in the direction of the first node 222 a to a secondhole 248 b in the free end 246 and then up to and around the adjacentfirst node 222 a. The elongated member 254 is then threaded back acrossthe cell 218 to the second node 222 b, to which the respective elongatedmember 254 is secured by tying or the like. The remaining five elongatedmembers 254 (not all of which are visible) can be threaded in a similarfashion. Similar to prior embodiments, when the stent frame 214 isallowed to expand via releasing tension in one or more compressionsutures 212 or otherwise, each elongated member 254 will be pulledacross the exterior circumference of the stent frame 214, thus alsopulling the wrap 240 into position from the delivery arrangement of FIG.4A to the deployed arrangement of FIGS. 4B-4C. As with the priordisclosed embodiments, the elongated members 254 can be of the typedisclosed above and a valve structure is not illustrated in the figuresfor clarity.

Another prosthetic valve 310 is generally illustrated in FIGS. 5A-5E. Inthis embodiment, the prosthetic valve 310 includes a wrap 340 and aplurality of elongated members 354 a equally spaced around acircumference of the wrap 340 that are woven approximately midwaythrough a width W of the wrap 340. FIGS. 5A and 5B are pre-assemblyviews illustrating the prosthetic valve 310 prior to the attachment ofelongated members 354 b and placement of the wrap 340 adjacent a stentframe 314 of the prosthetic valve 310 for delivery (see also, FIGS.5C-5E). To finalize the assembly of the wrap 340, secondary elongatedmembers 354 b are woven through the distal end 326 of the stent frame314 and a free end 346 of the wrap 340 and tied to form a closed loop(see, e.g. FIG. 5E). When the stent frame 314 expands, the wrap 340transitions from a delivery arrangement of FIG. 5C to a deployedarrangement of FIG. 5D and 5E. As the stent frame 314 expands due to therelease of compressive tension provided by compression sutures 312actuated by delivery device 1, the wrap 340 is pulled in such a way thatthe wrap 340 folds over the stent frame 314 and over itself at theelongated member 354 a such that the free end 346 and a secured end 344of the wrap 340 are in approximate alignment with each other at a firstend 326 of the stent frame 314 as is generally illustrated in FIG. 5E.This embodiment provides for a thicker wrap 340 once deployed, but doesnot add to the prosthetic valve 310 profile during delivery. A thickerwrap 340 in the deployed arrangement is believed to provide extrasealing capabilities to prevent paravalvular leakage as compared to theembodiments disclosed above. In this embodiment, there are two layers ofwrap body material 342 surrounding the first end 326 of the stent frame314, wherein the secured end 344 is approximately even with the free end346 in the deployed arrangement. As is best illustrated in FIG. 5B, eachelongated member 354 a is tied to a first node 322 a and it is threadedacross one cell 318 to a second node 322 b around which the elongatedmember 354 a is wound. The elongated member 354 then extends downthrough a hole 348 a approximately midway through the wrap 340. Then theelongated member 354 extends over to a second hole 348 b in the wrap 340and then up toward the first node 322 a. Except as explicitly stated,the wrap 340 and elongated members 354 can be of the type as describedwith respect to the embodiments above. As with the prior disclosedembodiments, a valve structure is not illustrated in the figures forclarity.

FIGS. 6A-6C schematically illustrate portions of yet an additionalprosthetic valve 410 (partially shown) having an inverting wrap 440secured to a stent frame 414 (also partially shown). As with the priordisclosed embodiments, the valve leaflets, as shown in FIGS. 1D and 1E,are not shown in FIGS. 6A-6C for clarity. The wrap 440 includes aproximal end 446, a distal end 444 and midsection 447 therebetween. Inthis embodiment, the proximal end 446 is most proximal with respect tothe stent frame 414 and is secured to the stent frame 414 withattachment sutures (not visible) or the like. The distal end 444 ispositioned distally as compared to the proximal end 446. The wrap 440 isalso secured to the stent frame 414 at two points 448 a, 448 b withinthe midsection 447 with a plurality of elongated member pairs (only oneelongated member pair 454 a, 454 b is shown in FIGS. 6A-6C). Eachelongated member pair includes two elongated members 454 a, 454 b, whichcan be woven around the stent frame 414 in any fashion disclosed herein.Various embodiments can include a plurality (e.g. six) elongated members454 a, 454 b similarly threaded and spaced equally around the stentframe 414. The elongated members 454 a, 454 b can be of the type asdisclosed with prior embodiments.

In one exemplary method of threading one pair of elongated members 454a, 454 b illustrated in FIGS. 6A-6C, the first elongated member 454 acan be tied or otherwise secured to a point 448 a in the midsection 447of the wrap 440 and then directed to a pivot point 422 a at an eyelet430 or other portion of the stent frame 414 through which the firstelongated member 454 a can be threaded through or around. The firstelongated member 454 a is then threaded to a second point 422 b at thestent frame 414 that is two cells 418 away. At the second point 422 b onthe stent frame 414, which can be an eyelet 430, the first elongatedmember 454 a is secured via tying or the like. The second elongatedmember 454 b is attached at a point 448 b in the midsection 477 of thewrap 440 and extends proximally to pivot node 422 c in stent frame 414around which the second elongated member 454 b is threaded and directedto a second node 422 d of the stent frame 414 that is two cells 418 awayat which the second elongated member 454 b is secured by tying or thelike. In one embodiment, the approximate distance from pivot node 422 cto the pivot point 422 a from the proximal end 446 is approximately onethird of a width of the wrap 440. In a further embodiment, the point 448b is approximately equal distance from 448 a as is from the proximal end446, which is approximately one third of a width of the wrap 440. Aswith prior disclosed embodiments, when the stent frame 414 expands fromthe delivery arrangement (FIG. 6A) to the deployed arrangement (FIG.6C), the expansion of the stent frame 414 correspondingly draws theelongated members 454 a, 454 b, thus pulling the midsection 447 of thewrap 440 toward the proximal end 446 of the wrap 440 so that the wrap440 becomes inverted and has a triple thickness along a least part ofthe wrap 440 (see, in particular, FIG. 6C). This embodiment is alsoparticularly useful in preventing a “parachute effect,” which may beobserved in prior disclosed embodiments where the wrap is drawn up andover the stent frame, which can collect blood and make it more difficultto flip the wrap from the delivery arrangement to the deployedarrangement.

As generally illustrated in FIGS. 7A-7B, a prosthetic valve 510(partially shown) is generally identical to the prosthetic valve 10 andcan be delivered and deployed with the delivery device 1 in the manneras schematically illustrated and described with respect to FIGS. 1A-1E.The prosthetic valve 510 includes a wrap 540 that generally comprises acylindrical body of material having a secured end 544 and a free end546. The secured end 544 of the wrap 540 is secured to the stent frame514. FIG. 7A generally depicts the prosthetic valve 510 held in acompressed, delivery arrangement. To fully deploy the wrap 540, aplurality of elongated members 554 are provided, which are configured toautomatically pull the wrap 540 into position upon expansion of theprosthetic valve 510 during deployment (only one demonstrative elongatedmember 554 is shown for ease of illustration). The plurality ofelongated members 554 can be equally spaced around the stent frame 514and attached proximate the free end 546 of the wrap 540. Each elongatedmember 554 extends from the free end 546, through apertures 528 in thewrap and extends to the stent frame 514 where it is wrapped around apivot node 522 a of the stent frame 514, then the elongated member 554is woven across two adjacent cells 518 of the stent frame 514 to asecond node 522 b to which the respective elongated member 554 isattached. This “two-cell” threading arrangement provides a sufficientamount of slack in the respective elongated member 554 to allow the wrap540 to be positioned sufficiently proximal to the stent frame 514 whenthe stent frame 514 is in the compressed, delivery configuration, as isillustrated in FIG. 7A. It will be understood that the number of cells518 in which the elongated member 554 spans can vary based on the stentframe 514 design. The elongated members 554 are woven and configured toprovide a length of travel required to pull the wrap 540 from thedelivery arrangement to the deployed arrangement. When the stent frame514 expands for deployment, each elongated member 554 is pulled acrossthe expanding exterior circumference of the stent frame 514, thus alsopulling the free end 546 of the wrap 540 proximally into position overthe stent frame 514 as is shown in FIG. 7B.

Similarly, a prosthetic valve 610 of FIGS. 8A-8B (partially shown) isgenerally identical to the prosthetic valve 10 and can be delivered anddeployed with the delivery device 1 in the manner as schematicallyillustrated and described with respect to FIGS. 1A-1E. The prostheticvalve 610 includes a wrap 640 that generally comprises a cylindricalbody of material having a secured end 644 and a free end 646. Thesecured end 644 of the wrap 640 can be secured to the stent frame 614.FIG. 8A generally depicts the prosthetic valve 610 held in a compressed,delivery arrangement. To fully deploy the wrap 640, a plurality ofelongated members 654 are provided, which are configured toautomatically pull the wrap 640 into position upon expansion of theprosthetic valve 610 during deployment (only one demonstrative elongatedmember 654 is shown for ease of illustration). The plurality ofelongated members 654 can be equally spaced around the stent frame 614and attached proximate the free end 646 of the wrap 640. Each elongatedmember 654 extends from the free end 646 and extends to the stent frame614 where it is wrapped around a pivot node 622 a of the stent frame614, then the elongated member 654 is woven across two adjacent cells618 of the stent frame 614 to a second node 622 b to which therespective elongated member 654 is attached. This “two-cell” threadingarrangement provides a sufficient amount of slack in the respectiveelongated member 654 to allow the wrap 640 to be positioned sufficientlyproximal to the stent frame 614 when the stent frame 614 is in thecompressed, delivery configuration, as is illustrated in FIG. 8A. Itwill be understood that the number of cells 618 in which the elongatedmember 654 spans can vary based on the stent frame 614 design. Theelongated members 654 are woven and configured to provide a length oftravel required to pull the wrap 640 from the delivery arrangement tothe deployed arrangement. When the stent frame 614 expands fordeployment, each elongated member 654 is pulled across the expandingexterior circumference of the stent frame 614, thus also pulling thefree end 646 of the wrap 640 proximally into position over the stentframe 614 as is shown in FIG. 8B.

In view of the present disclosure, it will be understood that there aremany ways in which the elongated members can be threaded and arrangedaround the stent frame to provide a configuration in which the elongatedmembers do not cross or contact each other, while still providing aplurality of elongated members to actuate transition of the wrap from adelivery arrangement to a deployment arrangement. Such embodimentsprovide for many points of attachment to ease actuation or flipping ofthe wrap, which movement is typically resisted by the patient's tissue.It will be further understood, in view of the teachings herein, thedirection in which the elongated members are wrapped around the stentframe can be clockwise, counterclockwise or a combination thereof.Additional configurations embodying this concept are intended to bewithin the scope of the present disclosure.

Various sutures disclosed herein can be of many types commonly used forcompressing stented prosthetic heart valves during delivery. In variousembodiments, the elongated members can be elastic so that the wrapreaches its full deployed arrangement before the stent frame is in thefull expanded deployed arrangement.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure.

What is claimed is:
 1. A stented prosthetic heart valve comprising: astent frame; a plurality of valve leaflets positioned within the stentframe; and a wrap connected to the stent frame with an elongated member,the wrap including first and second ends, the elongated member includingfirst and second ends, wherein the first end of the elongated member issecured to the stent frame, wherein the first end of the wrap is securedto the stent frame, wherein the second end of the wrap is connected tothe elongated member such that the second end of the wrap is movablyconnected to the stent frame, wherein the elongate member is threaded atleast once through the wrap, wherein the wrap has a deliveryconfiguration and a deployed configuration that is actuated by expansionof the stent frame.
 2. The prosthetic heart valve of claim 1, whereinthe stent frame includes a plurality of cells formed by segmentsadjoined at a plurality of nodes, wherein the elongated member extendsfrom the wrap in a first direction, wraps around one respective node andthen extends in a second direction that is different than the firstdirection.
 3. The prosthetic heart valve of claim 1, wherein the stentframe defines a length and the wrap covers a greater portion of thelength of the stent frame in the deployment configuration as compared tothe delivery configuration.
 4. The prosthetic heart valve of claim 1,wherein the stent frame includes first and second ends, the second endof the wrap extending beyond the first end of the frame in the deliveryconfiguration and the second end of the wrap extends over the stentframe in the deployed configuration.
 5. The prosthetic heart valve ofclaim 1, further comprising a plurality of elongated members connectingthe stent frame and the wrap, wherein each elongate member is threadedat least once through the wrap.
 6. The prosthetic heart valve of claim5, wherein the plurality of elongated members are arranged andconfigured so that they do not cross one another.
 7. The prostheticheart valve of claim 5, wherein the plurality of elongated members arearranged and configured to be offset such that in the deployedconfiguration, a plurality of ridges are formed in an outwardly facingsurface of the wrap.
 8. The prosthetic heart valve of claim 1, whereinthe stent frame includes a plurality of cells formed by segmentsadjoined at a plurality of nodes, wherein the elongated member isthreaded around a single respective one of the plurality of cells. 9.The prosthetic heart valve of claim 1, wherein the stent frame includesa plurality of cells formed by segments adjoined at a plurality ofnodes, wherein the elongated member is threaded around two respectivecells of the plurality of cells.
 10. The prosthetic heart valve of claim9, further comprising a plurality of elongated members connecting thestent frame and the wrap, wherein each of the plurality of elongatedmembers are each threaded around two respective cells of the pluralityof cells, wherein each of the plurality of elongated members are notthreaded around any of the respective cells around which another of theplurality of elongated members is threaded.
 11. The prosthetic heartvalve of claim 1, wherein the wrap is folded at least once in thedeployed configuration.
 12. The prosthetic heart valve of claim 1,wherein the elongate member is threaded a plurality of times through thewrap.